Men with pattern hair loss gained 43.9 hairs per square centimeter over 12 months on twice-daily doses of VDPHL01, an investigational oral minoxidil pill from Veradermics in New Haven. Men on once-daily doses gained 29.7.
The trial, called Study 302, enrolled 519 men. For the first six months, some took 8.5mg of the pill once a day, some took it twice a day and others took a placebo. Placebo patients then switched to the pill for the final six months.
Reid Waldman, MD, chief executive officer of Veradermics, said: “The 12-month long-term data from Study ‘302’ represent an important milestone in our efforts to provide a new standard of care for male pattern hair loss, demonstrating maintenance of improvement across all key efficacy endpoints and deepening of the target area hair count in the twice-daily VDPHL01 group. VDPHL01 was also well tolerated with no newly identified safety signals. These data support the potential of VDPHL01 to transform the treatment of pattern hair loss.”
After 12 months, 89.1% of men on twice-daily doses and 79.8% on once-daily doses reported visibly improved hair coverage. Investigators judged coverage improved in 92.2% and 74.4% of those groups, respectively. No serious side effects tied to treatment and no heart-related side effects of special interest were seen. Men who switched from placebo gained 32.1 hairs per square centimeter on twice-daily doses and 24.5 on once-daily doses. Michael Gold, MD, a board-certified dermatologist, is an investigator in the trial and a paid consultant of Veradermics.
“Pattern hair loss is epidemiologically the most common condition in dermatology; however, only a small fraction of patients seek prescription treatment, and an even smaller fraction of patients are satisfied with their treatment. Many patients hesitate to treat their pattern hair loss today because they are either concerned about safety of hormonal agents and off-label therapies or because they do not believe today’s treatments make visible hair regrowth a realistic possibility,” Gold said. “These results from Study ‘302’ and the overall VDPHL01 Phase 3 program give me hope that patients could finally have an option that meets their needs, potentially providing a reason for the tens of millions of people silently suffering on the sidelines to seek treatment.”
Study 304, in more than 500 men, produced results in October 2026. Results from Study 306, a trial in women, are expected in the first half of 2027.
